NDC 50419-422

Skyla 13.5 mg intrauterine device

On the label: Bayer HealthCare Pharmaceuticals Inc..

Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Bayer AGBergkamen, GermanyMakes the active ingredient and tests it Problems found, fixed voluntarilyNov 14, 2024 · 7 inspections, 1 with FDA action

Product details

Generic drug
Levonorgestrel: every company that makes it
Form
intrauterine device, intrauterine
Strength
13.5 mg
Approval
NDA NDA203159
On the market since
Jan 11, 2013
Package NDCs
50419-422-01 50419-422-08 50419-422-71
Official label
DailyMed (National Library of Medicine), updated Mar 4, 2026

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